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The aim of this study is to evaluate the effect of Roux-en-y gastric bypass (RYGB) in controlling diabetes in subjects with mild obesity (BMI 26-35). The primary endpoint will be the reduction of HbA1c (< 7%), a standard measure of diabetes control; the secondary endpoints will be changes blood sugar , vitamin levels, insulin, c-peptide, and lipids levels, as well as retinal eye examinations, urinalysis to assess kidney function, carotid ultrasound as a marker of cardiovascular function, and alterations in diabetic medications. Fifty subjects with medically documented type 2 Diabetes Mellitus (T2DM) with BMIs between 26 and 35 will undergo standard laparoscopic RYGB. Prior and after surgery, the subjects will undergo a clinical evaluation in regard to the primary and secondary endpoints listed. The pre-surgery evaluation is directed toward establishing the existence of diabetes related complications prior to surgery. After surgery subjects will be closely monitored for complications and required changes in their diabetes management. Repeat assessments will be made at 1, 3, 6, and 12 months and at two years.

All patients will be in a single arm receiving bypass surgery to assist with diabetes management

Procedure: Gastric bypass for diabetic patients <35 BMI

The operation is performed under general anesthesia. It is done laparoscopically, meaning that several small openings are made in the abdomen for insertion of long, thin surgical instruments, one with an attached camera. The operation is video monitored. The top of the stomach is divided across, leaving a small pouch for food. The rest of the stomach remains but can receive no food. The gut is divided just past the stomach, and it is attached to the small stomach pouch so that food can get back into the bowel. A second connection is made so that the bile and digestive juices pass into the bowel with the food.

Other Name: gastric bypass surgery

Detailed Description:

The primary endpoint will be the reduction of HbA1c and secondary endpoints will be multiple associated parameters as listed below. A group of 50 subjects with medically documented T2DM and BMI of 26-35 will undergo standard laparoscopic RYGB. Prior to surgery, the subjects will undergo the standard pre-operative work up required for conventional bariatric surgery. This includes full history and physical exam, medical/cardiac clearances as needed, nutrition consultation and a gastrointestinal consultation for upper endoscopy. After thorough explanation an approved informed consent will be signed. Baseline parameters, as listed below, will be measured for each subject to identify possible complications of diabetes prior to the surgical intervention..

After surgery perioperative complications will be monitored and required modifications of diabetes management advised. Followed up measurements at 1, 3, 6, 12, and 24 months is consistent with standard clinical practice guidelines. Data analysis will be ongoing to observe the effects of the surgical intervention on glucose homeostasis.

Baseline parameters

History and Physical Exam

Weight/BMI/ body composition with the Tanita 310.

Waist Circumference

Blood Pressure

CBC

HbA1c

Fasting glucose

Vitamin B6, B12, Folate,and Iron status

Lipid Profile -total cholesterol, HDL, LDL, triglyceride

Fasting Insulin and C-peptide

Stimulated C-peptide

EKG

Retinal exam

Urinalysis (assess for proteinuria and microalbuminuria)

Comprehensive foot exam

Medications and dosage

Quality of Life Score (SF-36)

Carotid ultrasound (intima-media thickness)

Follow-up:

4 Weeks:

Physical Examination, wound check, Body weight, BMI,

Glucose Diary (pre and postprandial glucose levels as required)

Insulin and C-peptide

Lipid profile

Medication use

3 Months, 6 months,

Same as above plus:

HbA1c

Vitamin levels and iron status

Retinal exam

Annually the baseline measurements will be repeated

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Adult males and females who meet the following inclusion criteria will be offered the opportunity to participate in the study:

Diagnosis of type 2 Diabetes Mellitus (T2DM) confirmed by the following criteria: